Biological Fluid Collection Device and Biological Fluid Collection System

ABSTRACT

A biological fluid collection device that is adapted to receive a blood sample is disclosed. The biological fluid collection device includes a housing, a puncturing element transitionable between a pre-actuated position wherein the puncturing element is retained within the housing and a puncturing position wherein at least a portion of the puncturing element extends through the housing, and a cartridge removably connectable to a portion of the housing. After collecting a blood sample, the cartridge is removable from the housing and the cartridge is able to transfer the blood sample to a point-of-care testing device. The biological fluid collection device provides a closed system that reduces the exposure of a blood sample and provides fast mixing of a blood sample with a sample stabilizer.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. Provisional ApplicationNo. 62/201,763 filed Aug. 6, 2015, the entire disclosure of which isherein incorporated by reference.

BACKGROUND OF THE INVENTION

Field of the Disclosure

The present disclosure relates generally to devices, assemblies, andsystems adapted for use with vascular access devices. More particularly,the present disclosure relates to devices, assemblies, and systemsadapted for collecting biological samples for use in point of caretesting.

Description of the Related Art

Blood sampling is a common health care procedure involving thewithdrawal of at least a drop of blood from a patient. Blood samples arecommonly taken from hospitalized, homecare, and emergency room patientseither by finger stick, heel stick, or venipuncture. Blood samples mayalso be taken from patients by venous or arterial lines. Once collected,blood samples may be analyzed to obtain medically useful informationincluding chemical composition, hematology, and coagulation, forexample.

Blood tests determine the physiological and biochemical states of thepatient, such as disease, mineral content, drug effectiveness, and organfunction. Blood tests may be performed in a clinical laboratory or atthe point-of-care near the patient. One example of point-of-care bloodtesting is the routine testing of a patient's blood glucose levels whichinvolves the extraction of blood via a finger stick and the mechanicalcollection of blood into a diagnostic cartridge. Thereafter, thediagnostic cartridge analyzes the blood sample and provides theclinician a reading of the patient's blood glucose level. Other devicesare available which analyze blood gas electrolyte levels, lithiumlevels, and ionized calcium levels. Some other point-of-care devicesidentify markers for acute coronary syndrome (ACS) and deep veinthrombosis/pulmonary embolism (DVT/PE).

Despite the rapid advancement in point-of-care testing and diagnostics,blood sampling techniques have remained relatively unchanged. Bloodsamples are frequently drawn using hypodermic needles or vacuum tubesattached to a proximal end of a needle or a catheter assembly. In someinstances, clinicians collect blood from a catheter assembly using aneedle and syringe that is inserted into the catheter to withdraw bloodfrom a patient through the inserted catheter. These procedures utilizeneedles and vacuum tubes as intermediate devices from which thecollected blood sample is typically withdrawn prior to testing. Theseprocesses are thus device intensive, utilizing multiple devices in theprocess of obtaining, preparing, and testing blood samples. Eachadditional device increases the time and cost of the testing process.Furthermore, mixing with an anticoagulant or other component tostabilize the sample must be performed manually.

Point-of-care testing devices allow for a blood sample to be testedwithout needing to send the blood sample to a lab for analysis. Thus, itis desirable to create a device that provides an easy, safe,reproducible, and accurate process with a point-of-care testing system.

SUMMARY OF THE INVENTION

The present disclosure provides a biological fluid collection devicethat is adapted to receive a blood sample. In accordance with anembodiment of the present invention, the biological fluid collectiondevice includes a housing having a receiving port and an inlet port. Theinlet port defines a housing flow channel therein in fluid communicationwith the inlet port. A puncturing element is at least partially disposedwithin the housing and transitionable between a pre-actuated positionwherein the puncturing element is retained within the housing and apuncturing position wherein at least a portion of the puncturing elementextends through the inlet port of the housing for establishing fluidcommunication with the housing flow channel. A cartridge defining acartridge flow channel is removably connectable to the receiving port ofthe housing. With the cartridge connected to the housing, the cartridgeflow channel is in fluid communication with the housing flow channel andwith the cartridge disconnected from the housing, the cartridge flowchannel is sealed. The housing flow channel of the biological fluidcollection device is adapted to receive a multi-component blood samplehaving a cellular portion and a plasma portion.

In one configuration, a sample stabilizer is disposed within a portionof the cartridge flow channel. A separation member may be disposed atleast partially within a portion of the cartridge flow channel. Theseparation member is configured to restrain the cellular portion andallow the plasma portion to pass therethrough.

In one configuration, the cartridge includes a cartridge inlet port influid communication with the housing flow channel when the cartridge isreceived within the receiving port of the housing and a transfer port influid communication with the cartridge flow channel. The cartridge flowchannel may include a serpentine shape. With the cartridge disconnectedfrom the receiving port, the transfer port is adapted for connection toa point-of-care testing device for transferring at least a portion ofthe multi-component blood sample from the cartridge to the point-of-caretesting device. The cartridge may include an actuation member in fluidtransfer communication with the transfer port. The actuation member istransitionable between an initial position in which the multi-componentblood sample is stored within the cartridge and an activated position inwhich at least a portion of the multi-component blood sample is expelledfrom the transfer port.

The cartridge may further include a valve disposed in fluidcommunication with the transfer port. The valve being transitionablebetween a closed position in which the transfer port is sealed and anopen position in which a portion of a multi-component blood sample isadapted to pass therethrough. In some configurations, the cartridgeincludes at least one resiliently deflectable arm releasably engagablewith an interference engagement located within the receiving port of thehousing for securing the cartridge to the housing. The cartridge mayinclude electronic or machine readable information, such as a barcode.

In accordance with another embodiment of the present invention, abiological fluid collection device includes a housing having a receivingport and a puncturing element at least partially disposed within thehousing. The puncturing element is moveable between a pre-actuatedposition, in which the puncturing element is retained within the housingand a puncturing position, in which at least a portion of the puncturingelement extends through the housing. A cartridge is removablyconnectable to the receiving port of the housing. The cartridge definesa flow channel therein. The cartridge includes a port in fluidcommunication with the flow channel for intake and expulsion of abiological fluid sample. The flow channel includes a sample stabilizerdisposed therein. The cartridge is adapted to receive a multi-componentblood sample having a cellular portion and a plasma portion via theport. In one embodiment, the puncturing element may be part of a contactactivated lancet device.

In one configuration the actuation member is in fluid transfercommunication with the flow channel. The actuation member istransitionable between an initial position in which the multi-componentblood sample is stored within the cartridge and an activated position inwhich at least a portion of the multi-component blood sample is expelledfrom the transfer port. In one embodiment, the actuation member istransitioned to the activated position only after a portion of themulti-component blood sample has mixed with the sample stabilizer. Aseparation member may be disposed at least partially within a portion ofthe flow channel. The separation member being configured to restrain thecellular portion and allow the plasma portion to pass therethrough. Withthe cartridge disconnected from the housing, the port is adapted forconnection to a point-of-care testing device for closed transfer of atleast a portion of the multi-component blood sample from the cartridgeto the point-of-care testing device.

In one configuration, the cartridge flow channel includes a vent toatmosphere. The vent may include a porous membrane adapted to allow airto pass, therethrough and retain the multi-component blood sampletherein.

BRIEF DESCRIPTION OF THE DRAWINGS

The above-mentioned and other features and advantages of thisdisclosure, and the manner of attaining them, will become more apparentand the disclosure itself will be better understood by reference to thefollowing descriptions of embodiments of the disclosure taken inconjunction with the accompanying drawings, wherein:

FIG. 1 is a perspective view of a biological fluid collection device inaccordance with an embodiment of the present invention.

FIG. 2 is an exploded, perspective view of the biological fluidcollection device of FIG. 1.

FIG. 3 is a top plan view of a cartridge with a readable informationportion in accordance with an embodiment of the present invention.

FIG. 4 is a perspective view of the biological fluid collection deviceof FIG. 1 in contact with a patient.

FIG. 5 is a top plan view of the biological fluid collection device ofFIG. 1.

FIG. 6 is a cross-sectional view of the biological fluid collectiondevice of FIG. 5, taken along line 6-6, of with a puncturing element ina puncturing position.

FIG. 7 is a cross-sectional view of the biological fluid collectiondevice of FIG. 5, taken along line 6-6, with the puncturing element in apre-actuated position.

FIG. 8 is a perspective view of the biological fluid collection deviceof FIG. 1 with a user removing a cartridge from a housing in accordancewith an embodiment of the present invention.

FIG. 9 is a perspective view of the biological fluid collection deviceof FIG. 8 after the user has removed the cartridge from the housing.

FIG. 10 is a perspective view of the cartridge of FIG. 8 with a userremoving a cap from the cartridge in accordance with an embodiment ofthe present invention.

FIG. 11 is a perspective view of the cartridge of FIG. 8, engaged with apoint-of-care testing device in accordance with an embodiment of thepresent invention.

FIG. 12 is a perspective view of a cartridge and a syringe assembly inaccordance with another embodiment of the present invention.

FIG. 13 is a top plan view of a biological fluid collection device inaccordance with another embodiment of the present invention.

FIG. 14 is a top plan view of the biological fluid collection device ofFIG. 13 having a cartridge removed from a housing.

FIG. 15 is a cross-sectional view of the cartridge of the biologicalfluid collection device of FIG. 14.

FIG. 16 is top plan view of the biological fluid collection device ofFIG. 13 with a first portion of the device being in contact with apatient.

FIG. 17 is a perspective view of the biological fluid collection deviceof FIG. 13 with a second portion of the device being in contact with apatient.

FIG. 18 is a perspective view of the cartridge of the biological fluidcollection device of FIG. 13 and a point-of-care testing device inaccordance with another embodiment of the present invention.

FIG. 19 is a cross-sectional view of a flow channel of a biologicalfluid collection device in accordance with an embodiment of the presentinvention.

FIG. 20 is a schematic representation of a separation member of abiological fluid collection device in accordance with an embodiment ofthe present invention.

FIG. 21 is a cross-sectional view of a puncturing element of a housingof a biological fluid collection device, with the puncturing element ina pre-actuated position, in accordance with an embodiment of the presentinvention.

FIG. 22 is a cross-sectional view of a puncturing element of a housingof a biological fluid collection device, with the puncturing element ina puncturing position, in accordance with an embodiment of the presentinvention.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate exemplary embodiments of the disclosure, and suchexemplifications are not to be construed as limiting the scope of thedisclosure in any manner.

DETAILED DESCRIPTION

The following description is provided to enable those skilled in the artto make and use the described embodiments contemplated for carrying outthe invention. Various modifications, equivalents, variations, andalternatives, however, will remain readily apparent to those skilled inthe art. Any and all such modifications, variations, equivalents, andalternatives are intended to fall within the spirit and scope of thepresent invention.

For purposes of the description hereinafter, the terms “upper”, “lower”,“right”, “left”, “vertical”, “horizontal”, “top”, “bottom”, “lateral”,“longitudinal”, and derivatives thereof shall relate to the invention asit is oriented in the drawing figures. However, it is to be understoodthat the invention may assume various alternative variations, exceptwhere expressly specified to the contrary. It is also to be understoodthat the specific devices illustrated in the attached drawings, anddescribed in the following specification, are simply exemplaryembodiments of the invention. Hence, specific dimensions and otherphysical characteristics related to the embodiments disclosed herein arenot to be considered as limiting.

Various point-of-care testing devices are known in the art. Suchpoint-of-care testing devices include test strips, glass slides,diagnostic cartridges, or other testing devices for testing andanalysis. Test strips, glass slides, and diagnostic cartridges arepoint-of-care testing devices that receive a blood sample and test thatblood for one or more physiological and biochemical states. There aremany point-of-care devices that use cartridge based architecture toanalyze very small amounts of blood bedside without the need to send thesample to a lab for analysis. This saves time in getting results overthe long run but creates a different set of challenges versus the highlyroutine lab environment. Examples of such testing cartridges include thei-STAT® testing cartridge from the Abbot group of companies. Testingcartridges such as the i-STAT® cartridges may be used to test for avariety of conditions including the presence of chemicals andelectrolytes, hematology, blood gas concentrations, coagulation, orcardiac markers. The results of tests using such cartridges are quicklyprovided to the clinician.

However, the samples provided to such point-of-care testing cartridgesare currently manually collected with an open system and transferred tothe point-of-care testing cartridge in a manual manner that often leadsto inconsistent results, or failure of the cartridge leading to a repeatof the sample collection and testing process, thereby negating theadvantage of the point-of-care testing device. Accordingly, a needexists for a system for collecting and transferring a sample to apoint-of-care testing device that provides safer, reproducible, and moreaccurate results. Accordingly, a point-of-care collecting andtransferring system of the present disclosure will be describedhereinafter. A system of the present disclosure enhances the reliabilityof the point-of-care testing device by: 1) incorporating a more closedtype of sampling and transfer system; 2) minimizing open exposure of thesample; 3) improving sample quality; 4) improving the overall ease ofuse; 5) separating the sample at the point of collection; and 6)stabilizing the sample at the point of collection.

FIGS. 1-11 illustrate an exemplary embodiment of a biological fluidcollection device of the present disclosure. Referring to FIGS. 1-11,19, and 20, a biological fluid collection device 10 of the presentdisclosure is adapted to receive a multi-component blood sample 12having a cellular portion 14 and a plasma portion 16. The biologicalfluid collection device 10 provides a closed system that reduces theexposure of a blood sample and provides fast mixing of a blood samplewith a sample stabilizer.

The biological fluid collection device 10 generally includes a housing20, a puncturing element 22, and a cartridge 24 removably connectable toa portion of the housing 20.

The housing 20 includes a sidewall 30, a bottom wall 32, a top wall 34,an actuation mechanism 36, an inlet port 38, a flow channel 40 definedwithin the housing 20 and in fluid communication with the inlet port 38,and a receiving port 42. In one embodiment, the actuation mechanism 36is a push button. The sidewall 30, the bottom wall 32, and the top wall34 of the housing 20 define an internal cavity 44 therein.

The bottom wall 32 of the housing 20 may include a mechanism forremovably adhering the biological fluid collection device 10 to apatient as shown in FIGS. 4, 6, and 7. For example, the bottom wall 32of the housing 20 may include an adhesive so that the biological fluidcollection device 10 can be secured onto a skin surface S of a patientwhere a blood sample will be accessed. In one embodiment, the adhesiveof the bottom wall 32 is protected by a peel-off layer, similar to anadhesive bandage, which would be removed before placing the biologicalfluid collection device 10 on the skin surface S of the patient's body.A hydrogel or other layer (not shown) could be included to provide somethickness to the bottom wall 32 and help improve the stability of theadhesive seal. Additionally, the adhesive could include a chemistry tocreate a more liquid-tight seal, similar to painter's tape technology,where wetting from the paint itself causes a chemical reaction with theadhesive to create an improved water-tight barrier to prevent the paintfrom seeping under the tape. Importantly, the adhesive provides forproper adhesion of the bottom wall 32 of the biological fluid collectiondevice 10 to the skin surface S of a patient and minimizes skin contactwhich leads to a better sample for coagulation testing. The adhesive ofthe bottom wall 32 can be punctured by the puncturing element 22 suchthat the blood evolving from the wound passes into the inlet port 38. Inone embodiment, the bottom wall 32 includes two layers, a bottom portionhaving an adhesive layer that is in contact with the skin and an upperportion that receives the evolving blood. The adhesive of the presentdisclosure includes an anti-leak mechanism. For example, in oneembodiment, a self-sealing or self-healing polymer is used. In anotherembodiment, the top wall 34 of the housing 20 comprises a dome-shapedwall, which compresses under the puncturing element 22, but which popsback to its original shape after a lancing action thereby providing avacuum force that helps pull the blood out of the wound.

The cartridge 24 is removably connectable to a portion of the housing20, such as the receiving port 42. The cartridge 24 includes an inletport 50 in fluid communication with the inlet port 38 of the housing 20via the flow channel 40, an entry reservoir 52 in fluid communicationwith the inlet port 50, a cartridge flow channel 54 defined within thecartridge 24 and in fluid communication with the entry reservoir 52, anexit reservoir 56 in fluid communication with the cartridge flow channel54, an exit port or transfer port 58 in fluid communication with theexit reservoir 56, a valve 60 disposed in communication with the exitport 58, an end cap 62, a fill indicator 64, a readable informationportion 66, arms 67, and a cartridge actuation member 68. In oneembodiment, the end cap 62 is removably attachable to the cartridge 24to seal the exit port 58. In one embodiment the arms 67 of the cartridge24 are resiliently deflectable. Referring to FIGS. 8 and 9, thecartridge 24 can be removed from the housing 20 by squeezing the arms 67to deflect the arms 67 out of engagement with an interference surface 69disposed within the receiving port 42 of the housing 20.

In one embodiment, the fill indicator 64 comprises a transparent wall ina portion of the cartridge 24. In this manner, after a user has drawn asufficient blood sample 12 into the cartridge 24 via the inlet port 38of the housing 20, the fill indicator 64 turns red, thereby indicatingthat a portion of the entry reservoir 52, the cartridge flow channel 54,and/or the exit reservoir 56 adjacent the fill indicator 64 is full,thus, signaling to the user to stop drawing the blood sample 12.

In one embodiment, referring to FIG. 3, at least a part of the readableinformation 66 may include electronically readable information and/ormachine readable information, a portion of which may be a barcode. Forexample, in one embodiment, included on a portion of the cartridge 24 isa barcode or some other machine readable data that is unique to eachcartridge 24 or optionally unique to the contents of each cartridge 24.Such information may also be used for storage of additional dataassociated with a cartridge, such as cartridge manufacturer information,cartridge type, intended draw size information, and the like. Inaddition, patient-specific, test-specific, or other application-specificinformation may be stored, e.g., electronically, and associated with thecartridge's unique identifier.

In one embodiment, the cartridge flow channel 54 comprises a serpentineshape. In some embodiments, the cartridge flow channel 54 comprises aserpentine shape to promote efficient mixing of a blood sample 12 havinga cellular portion 14 and a plasma portion 16. It is noted herein thatthe serpentine shape of the flow channel 54 may include undulations inthe left and right, fore and aft, up and down, directions or anycombinations thereof to promote efficient mixing of a blood sample 12.

The valve 60 is transitionable between a closed position to seal a bloodsample 12 within the exit reservoir 56 of the cartridge 24 and an openposition to allow a portion of the blood sample 12 to flow through theexit port 58 to a point-of-care testing device 90 as shown in FIG. 11.FIG. 11 is not drawn to scale. For example, the cartridge 24 of thepresent disclosure can be sized smaller in proportion to the size of ahand of a user. In FIG. 11, the cartridge 24 is illustrated larger inscale for clarity purposes only.

Referring to FIGS. 1 and 4-7, with the cartridge 24 connected to thehousing 20, the cartridge flow channel 54 is in fluid communication withthe inlet port 38 of the housing 20 via the flow channel 40.

With the cartridge 24 disconnected from the housing 20, the cartridgeflow channel 54 is sealed. In some embodiments, the cartridge 24 isremovably connected to the housing 20 via a frangible element orfrangible portion (not shown). The frangible element includes afrangible element sealing wall. In this manner, after the frangibleelement is broken to remove the cartridge 24 from the housing 20, thefrangible element sealing wall is configured to seal the inlet port 50of the cartridge 24. In other configurations, the cartridge 24 may beengaged with the housing 20 through a mechanical interlock.

The cartridge actuation member 68 is in communication with the exitport. The actuation member 68 is transitionable between an initialposition in which the multi-component blood sample 12 is storable withinthe cartridge 24 and an activated position in which the multi-componentblood sample 12 is expelled from the exit port 58.

The puncturing element 22 is at least partially disposed within thehousing 20 and is transitionable between a pre-actuated position (FIG.7) wherein the puncturing element 22 is retained within the housing 20and a puncturing position (FIG. 6) wherein at least a portion of thepuncturing element 22 extends through the inlet port 38 of the housing20 establishing fluid communication with the flow channel 40. In oneembodiment, the housing 20 and the puncturing element 22 are part of alancet microarray device.

Referring to FIGS. 6 and 7, the puncturing element 22 includes a forwardend 70, a backward end 72, a puncturing end 74 at the forward end 70 ofthe puncturing element 22, and a spring 76.

The puncturing element 22 is adapted for axial or longitudinal movementthrough the internal cavity 44 of the housing 20 between an initialarmed or pre-actuated position (FIG. 7) with the puncturing end 74maintained within the housing 20 to a puncturing position (FIG. 6) inwhich the puncturing end 74 extends through the inlet port 38 of thehousing 20. Puncturing end 74 is adapted for puncturing the skin surfaceS of a patient, and may define a pointed end, a blade edge, and thelike. Puncturing end 74 may include a preferred alignment orientation,such as with a pointed end of a blade aligned in a specific orientation.

Referring to FIGS. 6 and 7, the spring 76 may be provided around thepuncturing element 22 for retracting the puncturing end 74 within thehousing 20 after the puncturing end 74 is axially moved to thepuncturing position. The spring 76 extends between a surface of thebottom wall 32 of the housing 20 and the actuation mechanism 36. Thespring 76 is typically a compression spring, capable of storing energywhen in a compressed state.

A user or an operator may actuate or activate the actuation mechanism 36of the housing 20 to move the puncturing element 22 from thepre-actuation position (FIG. 7) to the puncturing position (FIG. 6)thereby causing the lancing of the skin surface S of the patient by thepuncturing end 74 as shown in FIG. 6. When the actuation mechanism 36 ofthe housing 20 is depressed, the puncturing end 74 cuts into the skinsurface S of the patient's body and capillary blood begins to flow intothe inlet port 38 of the housing 20. In one embodiment, a wickingelement may surround the inlet port 38, creating a chamber to pool theblood and by a wicking motion collect the blood, pulling it into thehousing 20.

In one embodiment, the biological fluid collection device 10 of thepresent disclosure provides a closed sampling and transfer system thatreduces the exposure of a blood sample and provides fast mixing of ablood sample with a sample stabilizer 80.

For example, referring to FIG. 19, the cartridge 24 is adapted tocontain a sample stabilizer 80 to provide passive and fast mixing of ablood sample 12 with the sample stabilizer 80. The sample stabilizer 80,can be an anticoagulant, or a substance designed to preserve a specificelement within the blood such as, for example, RNA, protein analyte, orother element. In one embodiment, the sample stabilizer 80 is heparin orEDTA. In one embodiment, a plurality of biological fluid collectiondevices 10 could include different sample stabilizers. A biologicalfluid collection device 10 of the present disclosure providesflexibility in the nature of the additives and/or sample stabilizersintroduced for a blood sample.

In one embodiment, the sample stabilizer 80 is provided within a portionof the cartridge flow channel 54. In other embodiments, the samplestabilizer 80 is provided in other areas of the biological fluidcollection device 10 such as the housing 20.

In one embodiment, the biological fluid collection device 10 includes asample stabilizer 80 disposed within a portion of the cartridge flowchannel 54. In one embodiment, the flow channel 54 may also includeagitation members 81. The agitation members 81 can control a flowpattern of the blood sample 12 to induce mixing of the blood sample 12and the sample stabilizer 80. In one embodiment, the agitation members81 can be in the form of a flute or rib that is co-molded with the flowchannel 54 and the sample stabilizer 80 can be coated on the flutesand/or on an inner sidewall surface 82 of the flow channel 54.

In one embodiment, the biological fluid collection device 10 of thepresent disclosure is adapted to receive a blood sample 12 having acellular portion 14 and a plasma portion 16. After collecting the bloodsample 12, the biological fluid collection device 10 is able to separatethe plasma portion 16 from the cellular portion 14. After separation,the biological fluid collection device 10 is able to transfer the plasmaportion 16 of the blood sample 12 to a point-of-care testing device.

Referring to FIG. 20, in one embodiment, the biological fluid collectiondevice 10 includes a blood separation element or separation member 84disposed at least partially within a portion of the cartridge flowchannel 54 between the inlet port 50 and the exit port 58. The bloodseparation element 84 is adapted to trap the cellular portion 14 of theblood sample 12 within the flow channel 54 and allow the plasma portion16 of the blood sample 12 to pass through the blood separation element84 to the exit port 58 as shown in FIG. 20.

In one embodiment, the blood separation element 84 is disposed within aportion of the flow channel 54 and the blood separation element 84 isadapted to restrain a cellular portion 14 of the multi-component bloodsample 12 and to allow a plasma portion 16 of the multi-component bloodsample 12 to pass therethrough.

In one embodiment, the blood separation element 84 may be either hollowfiber membrane filters commercially available, or flat membrane filters,such as track-etch filters commercially available. Membrane filter poresize and porosity can be chosen to optimize separation of clean (i.e.,red blood cell free, white blood cell free, and platelet free) plasma inan efficient manner. In another embodiment, the blood separation element84 includes a lateral flow membrane. In other embodiments, the bloodseparation element 84 may comprise any filter that is able to trap thecellular portion 14 of the blood sample 12 within the flow channel 54and allow the plasma portion 16 of the blood sample 12 to pass throughthe blood separation element 84 to the exit port 58.

Referring to FIG. 11, with the cartridge 24 disconnected from thehousing 20, the exit port 58 is adapted for connection to apoint-of-care testing device 90 for closed transfer of at least aportion of the multi-component blood sample 12 from the cartridge 24 tothe point-of-care testing device 90.

Referring again to FIGS. 1-11, use of a biological fluid collectiondevice 10 of the present disclosure will now be described. Referring toFIG. 4, upon selecting a site, a user, an operator, or a clinician mayadhere the biological fluid collection device 10 over a selectedsampling site.

A user may then actuate or activate the actuation mechanism 36 of thehousing 20 to move the puncturing element 22 from the pre-actuationposition (FIG. 7) to the puncturing position (FIG. 6) thereby causingthe lancing of the skin surface S of the patient by the puncturing end74 as shown in FIG. 6. When the actuation mechanism 36 of the housing 20is depressed, the puncturing end 74 cuts into the skin surface S of thepatient's body and capillary blood begins to flow into the inlet port 38of the housing 20.

Referring to FIGS. 8 and 9, when the cartridge 24 is filled with a bloodsample 12, the clinician can remove the cartridge 24 from the housing20. When removed from the housing 20, the flow channel 54 of thecartridge 24 is sealed from the external environment.

In some embodiments, the cartridge 24 of the biological fluid collectiondevice 10 can be used to separate the plasma portion 16 from thecellular portion 14 of the blood sample 12 using the blood separationelement 84 and the blood sample 12 can be mixed with a sample stabilizer80 as described above.

Referring to FIGS. 10 and 11, after the blood sample 12 is stabilizedand separated, a user may remove the end cap 62 from the cartridge 24and the cartridge 24 may be engaged with a blood testing device orpoint-of-care testing device 90 for closed transfer of a portion of thehomogenously stabilized blood sample from the biological fluidcollection device 10 to the blood testing device or point-of-caretesting device 90. The blood testing device 90 is adapted to receive thehomogenously stabilized blood sample to analyze the homogenouslystabilized blood sample and obtain test results.

With the cartridge 24 engaged with a blood testing device 90, a user maydepress the cartridge actuation member 68 to move the cartridgeactuation member 68 to an activated position in which themulti-component blood sample 12 is expelled from the exit port 58 to theblood testing device 90.

In one embodiment, referring to FIG. 11, the exit port 58 of thecartridge 24 may be engaged with a point-of-care testing device 90. Forexample, the exit port 58 may be placed over a receiving port 92 of thepoint-of-care testing device 90 as shown in FIG. 11. Next, a clinicianmay transfer a portion of a blood sample 12, e.g., a plasma portion 16of the blood sample 12, to the point-of-care testing device 90 in aclosed manner, reducing exposure to the clinician and the patient. Thepoint-of-care testing device 90 is adapted to receive the exit port 58of the cartridge 24 for closed transfer of a portion of the plasmaportion 16 of the blood sample 12 from the cartridge 24 to thepoint-of-care testing device 90. The point-of-care testing device 90 isadapted to receive the plasma portion 16 to analyze the blood sample andobtain test results.

FIG. 12 illustrates another exemplary embodiment and includes similarcomponents to the embodiment illustrated in FIGS. 1-11. For the sake ofbrevity, these similar components and the similar steps of usingbiological fluid collection device 100 will not all be discussed inconjunction with FIG. 12.

The biological fluid collection device 100 may include a syringe 150that is connectable to an exit port 58 and/or an end cap 62 of thecartridge 24 of the biological fluid collection device 100. The syringe150 includes a syringe barrel 152, a stopper 154 slideably disposedwithin an interior 156 of the syringe barrel 152, and a plunger rod 158connected to the stopper 154. The plunger rod 158 is moveable withrespect to the syringe barrel 152 to alter the position of the stopper154 within the syringe barrel 152.

For example, with the syringe 150 connected to the cartridge 24,retraction of the plunger rod 158 with respect to the syringe barrel 152in a direction generally along arrow A (FIG. 12) draws a multi-componentblood sample 12 within the cartridge 24 through a separation member 84(FIG. 20) within the cartridge 24. In one embodiment, the bloodseparation element 84 is disposed within a portion of the cartridge 24and the blood separation element 84 is adapted to restrain a cellularportion 14 of the multi-component blood sample 12 and to allow a plasmaportion 16 of the multi-component blood sample 12 to pass therethrough.

FIGS. 13-18, 21, and 22 illustrate another exemplary embodiment of abiological fluid collection device of the present disclosure. Referringto FIGS. 13-22, a biological fluid collection device 200 of the presentdisclosure is adapted to receive a multi-component blood sample 12having a cellular portion 14 and a plasma portion 16. The biologicalfluid collection device 200 provides a closed system that reduces theexposure of a blood sample and provides fast mixing of a blood samplewith a sample stabilizer.

The biological fluid collection device 200 generally includes a housing220, a puncturing element 222, and a cartridge 224 removably connectableto a portion of the housing 220. The housing 220 defines a receivingport 242 adapted to receive the cartridge 224 and an internal cavity 244in which the puncturing element 222 is disposed. The puncturing element222 includes a puncturing end 274.

Referring to FIGS. 21 and 22, in one embodiment, the housing 220 and thepuncturing element 222 are part of a contact activated lancet device246. The puncturing element 222 is moveable between a pre-actuatedposition (FIG. 21) wherein the puncturing element 222 is retained withinthe housing 220 and a puncturing position (FIG. 22) wherein at least aportion of the puncturing element 222 extends through the housing 220.

The puncturing element 222 is adapted for axial or longitudinal movementthrough the internal cavity 244 of the housing 220 between an initialarmed or pre-actuated position (FIG. 21) with the puncturing end 274maintained within the housing 220 to a puncturing position (FIG. 22) inwhich the puncturing end 274 extends through the housing 220. Puncturingend 274 is adapted for puncturing the skin surface S of a patient, andmay define a pointed end, a blade edge, and the like. Puncturing end 274may include a preferred alignment orientation, such as with a pointedend of a blade aligned in a specific orientation.

In one embodiment, the biological fluid collection device 200 includes atab member 248 removably securable to a portion of the housing 220 toenclose and shield the puncturing element 222.

Referring to FIGS. 13-18, the cartridge 224 is removably connectable toa portion of the housing 220 and defines a cartridge flow channel 254therein. The cartridge 224 includes a port 250. The cartridge flowchannel 254 is in fluid communication with the port 250. In oneembodiment, a connecting portion 241 of the cartridge 224 is removablyconnectable to the receiving port 242 of the housing 220 via a snap fitconnection. In one embodiment, the cartridge flow channel 254 includes avent 269 to atmosphere. The cartridge 224 is adapted to receive amulti-component blood sample 12 having a cellular portion 14 and aplasma portion 16 via the port 250.

As shown in FIG. 16, after the puncturing element 222 pierces the skin Sof the patient, the port 250 of the cartridge 224 includes a ventedportion that pulls off a first drop of blood. In one embodiment, theport 250 of the cartridge 224 includes a vent or a vent hole. In anotherembodiment, the port 250 of the cartridge 224 contains a small sponge ora wicking material that assists in drawing a first drop of blood. Inother embodiments, the port 250 of the cartridge 224 may include anymechanism that is adapted to pull a first drop of blood into thecartridge flow channel 254.

As shown in FIG. 17, the cartridge 224 also includes an actuation member268 in fluid communication with the port 250. Referring to FIG. 15, thecartridge flow channel 254 may generally be serpentine shaped includingundulations in the left and right, fore and aft, up and down, directionsor any combinations thereof to promote efficient mixing of a bloodsample 12. The flow channel 254 may comprise a reservoir 256 for storingthe multi-component blood sample 12 therein. In one particularembodiment, the flow channel 254 includes an inlet flow channel 255extending between the port 250 and the reservoir 256 and an outlet flowchannel 257 extending between the reservoir and the port 250. A one-wayvalve 261 is disposed between the inlet flow channel 255 and thereservoir 256 to prevent the multi-component blood sample 12 fromflowing back into the inlet flow channel 255 after entering thereservoir 256. A one-way valve 263 may also be disposed within theoutlet flow channel 257 adjacent the port 250 to prevent themulti-component blood sample 12 from entering the cartridge 224 via theoutlet port 257.

The actuation member 268 of the cartridge 224 is transitionable betweenan initial position in which a multi-component blood sample 12 isstorable within the cartridge 224 and an activated position in which themulti-component blood sample 12 is expelled from the port 250. In oneembodiment, the actuation member 268 is a plunger.

In one embodiment, the port 250 and/or the cartridge flow channel 254 ofthe cartridge 224 includes a porous membrane adapted to allow air toescape and retain the multi-component blood sample 12 within thecartridge flow channel 254. In this manner, once a blood sample 12 isreceived within the cartridge flow channel 254 of the cartridge 224, theblood sample 12 must be forced out the cartridge 224 to expel the bloodsample 12 from the cartridge 224. For example, in one embodiment, theactuation member 268 is used to force the blood sample 12 out thecartridge 224 by transitioning the actuation member 268 to the activatedposition, e.g., by depressing the actuation member 268 as shown in FIG.18.

With continued reference to FIG. 18, the biological fluid collectiondevice 200 of the present disclosure provides a closed sampling andtransfer system that reduces the exposure of a blood sample and providesfast mixing of a blood sample with a sample stabilizer 80.

For example, the cartridge 224 is adapted to contain a sample stabilizer80 to provide passive and fast mixing of a blood sample 12 with thesample stabilizer 80. The sample stabilizer 80, can be an anticoagulant,or a substance designed to preserve a specific element within the bloodsuch as, for example, RNA, protein analyte, or other element. In oneembodiment, the sample stabilizer 80 is heparin or EDTA. In oneembodiment, a plurality of biological fluid collection devices 200 couldinclude different sample stabilizers. A biological fluid collectiondevice 200 of the present disclosure provides flexibility in the natureof the additives and/or sample stabilizers introduced for a bloodsample. The sample stabilizer 80 may be provided within a portion of thecartridge flow channel 254.

In one embodiment, the flow channel 254 may also include agitationmembers 81. The agitation members 81 can control a flow pattern of theblood sample 12 to induce mixing of the blood sample 12 and the samplestabilizer 80. In one embodiment, the agitation members 81 can be in theform of a flute or rib that is co-molded with the flow channel 254 andthe sample stabilizer 80 can be coated on the flutes and/or on an innersidewall surface 282 of the flow channel 254.

In one embodiment, the cartridge 224 of the biological fluid collectiondevice 200 of the present disclosure is adapted to receive a bloodsample 12 having a cellular portion 14 and a plasma portion 16. Aftercollecting the blood sample 12, the cartridge 224 is able to separatethe plasma portion 16 from the cellular portion 14. After separation,the cartridge 224 is able to transfer the plasma portion 16 of the bloodsample 12 to a point-of-care testing device.

Referring to FIG. 20, in one embodiment, the cartridge 224 includes ablood separation element or separation member 284 disposed at leastpartially within a portion of the cartridge flow channel 254, forexample, the reservoir 256. The blood separation element 284 is adaptedto trap the cellular portion 14 of the blood sample 12 within the flowchannel 254 and allow the plasma portion 16 of the blood sample 12 topass through the blood separation element 284 to the port 250.

The blood separation element 284 may include commercially availablehollow fiber membrane filters, or flat membrane filters, such astrack-etch filters, also commercially available. Membrane filter poresize and porosity can be chosen to optimize separation of clean (i.e.,red blood cell free, white blood cell free, and platelet free) plasma inan efficient manner. In another embodiment, the blood separation element284 includes a lateral flow membrane. In other embodiments, the bloodseparation element 284 may comprise any filter that is able to trap thecellular portion 14 of the blood sample 12 within the flow channel 254and allow the plasma portion 16 of the blood sample 12 to pass throughthe blood separation element 284 to the port 250.

Referring to FIG. 18, with the cartridge 224 disconnected from thehousing 220, the port 250 is adapted for connection to a point-of-caretesting device 90 for closed transfer of at least a portion of themulti-component blood sample 12 from the cartridge 224 to thepoint-of-care testing device 90.

Referring to FIGS. 13-21, use of a biological fluid collection device200 of the present disclosure will now be described. Upon selecting asite, a user, an operator, or a clinician may position the housing 220of the biological fluid collection device 200 over a selected samplingsite, as shown by FIG. 16.

A user may then actuate or activate the puncturing element 222 to movethe puncturing element 222 from the pre-actuation position (FIG. 21) tothe puncturing position (FIG. 22) thereby causing the lancing of theskin surface S of the patient by the puncturing end 274 as shown in FIG.22. In this manner, the puncturing end 274 cuts into the skin surface Sof the patient's body and capillary blood begins to flow.

Referring to FIGS. 21 and 22, the housing 220 and the puncturing element222 are part of a contact activated lancet device 246. To actuate thepuncturing element 222 of a contact activated lancet device 246, theuser needs only to place the housing 220 against a skin surface S andthen exert a downwardly directed force on the housing 220 forcing thepuncturing element 222 against skin surface S.

Referring to FIG. 17, once blood is flowing, the port 250 of thecartridge 224 is placed adjacent the blood of the skin surface S of thepatient's body. In one embodiment, the port 250 of the cartridge 224includes a vented portion that pulls off a first drop of blood. Once thecartridge 224 is filled with a blood sample 12, the clinician can removethe cartridge 224 from the housing 220.

In some embodiments, the cartridge 224 of the biological fluidcollection device 200 can be used to separate the plasma portion 16 fromthe cellular portion 14 of the blood sample 12 using the bloodseparation element 284 and the blood sample 12 can be mixed with asample stabilizer 80 as described above.

Referring to FIG. 18, after the blood sample 12 is stabilized andseparated, the cartridge 224 may be engaged with a blood testing deviceor point-of-care testing device 90 for closed transfer of a portion ofthe homogenously stabilized blood sample from the biological fluidcollection device 200 to the blood testing device or point-of-caretesting device 90. The blood testing device 90 is adapted to receive thehomogenously stabilized blood sample to analyze the homogenouslystabilized blood sample and obtain test results.

With cartridge 224 engaged with a blood testing device 90, a user maydepress the actuation member 268 to move the actuation member 268 to anactivated position in which the multi-component blood sample 12 isexpellable from the port 250 of the cartridge 224 to the blood testingdevice 90. For example, the port 250 may be placed over a receiving port92 of the point-of-care testing device 90. Next, a clinician maytransfer a portion of a blood sample 12, e.g., a plasma portion 16 ofthe blood sample 12, to the point-of-care testing device 90 in a closedmanner, reducing exposure to the clinician and the patient. Thepoint-of-care testing device 90 is adapted to receive the port 250 ofthe cartridge 224 for closed transfer of a portion of the plasma portion16 of the blood sample 12 from the cartridge 224 to the point-of-caretesting device 90. The point-of-care testing device 90 is adapted toreceive the plasma portion 16 to analyze the blood sample and obtaintest results.

While this disclosure has been described as having exemplary designs,the present disclosure can be further modified within the spirit andscope of this disclosure. This application is therefore intended tocover any variations, uses, or adaptations of the disclosure using itsgeneral principles. Further, this application is intended to cover suchdepartures from the present disclosure as come within known or customarypractice in the art to which this disclosure pertains and which fallwithin the limits of the appended claims.

What is claimed is:
 1. A biological fluid collection device, comprising:a housing having a receiving port and an inlet port, the inlet portdefining a housing flow channel therein, the housing flow channel influid communication with the inlet port; a puncturing element at leastpartially disposed within the housing and transitionable between apre-actuated position wherein the puncturing element is retained withinthe housing and a puncturing position wherein at least a portion of thepuncturing element extends through the inlet port of the housing forestablishing fluid communication with the housing flow channel; and acartridge removably connectable to the receiving port of the housing,the cartridge defining a cartridge flow channel therein, wherein, withthe cartridge connected to the housing, the cartridge flow channel is influid communication with the housing flow channel, and wherein, with thecartridge disconnected from the housing, the cartridge flow channel issealed.
 2. The biological fluid collection device of claim 1, furthercomprising a sample stabilizer disposed within a portion of thecartridge flow channel.
 3. The biological fluid collection device ofclaim 1, wherein the housing flow channel of the biological fluidcollection device is adapted to receive a multi-component blood samplehaving a cellular portion and a plasma portion.
 4. The biological fluidcollection device of claim 3, further comprising a separation memberdisposed at least partially within a portion of the cartridge flowchannel, the separation member adapted to restrain the cellular portionand allow the plasma portion to pass therethrough.
 5. The biologicalfluid collection device of claim 3, wherein the cartridge includes acartridge inlet port in fluid communication with the housing flowchannel when the cartridge is received within the receiving port of thehousing and a transfer port in fluid communication with the cartridgeflow channel.
 6. The biological fluid collection device of claim 5,wherein with the cartridge disconnected from the receiving port, thetransfer port is adapted for connection to a point-of-care testingdevice for transferring at least a portion of the multi-component bloodsample from the cartridge to the point-of-care testing device.
 7. Thebiological fluid collection device of claim 6, wherein the cartridgeincludes an actuation member in fluid transfer communication with thetransfer port, the actuation member transitionable between an initialposition in which the multi-component blood sample is stored within thecartridge and an activated position in which at least a portion of themulti-component blood sample is expelled from the transfer port.
 8. Thebiological fluid collection device of claim 5, wherein the cartridgefurther comprises a valve disposed in fluid communication with thetransfer port, the valve being transitionable between a closed positionin which the transfer port is sealed and an open position in which aportion of a multi-component blood sample is adapted to passtherethrough.
 9. The biological fluid collection device of claim 1,wherein the cartridge further comprises at least one resilientlydeflectable arm, the resiliently deflectable arm being releasablyengagable with an interference engagement located within the receivingport of the housing for securing the cartridge to the housing.
 10. Thebiological fluid collection device of claim 1, wherein the cartridgeflow channel has a serpentine shape.
 11. The biological fluid collectiondevice of claim 1, wherein a portion of the cartridge includeselectronic or machine readable information.
 12. The biological fluidcollection device of claim 11, wherein the electronic or machinereadable information comprises a barcode.
 13. A biological fluidcollection device, comprising: a housing having a receiving port and apuncturing element at least partially disposed within the housing, thepuncturing element moveable between a pre-actuated position wherein thepuncturing element is retained within the housing and a puncturingposition wherein at least a portion of the puncturing element extendsthrough the housing; and a cartridge removably connectable to thereceiving port of the housing, the cartridge defining a flow channeltherein, the cartridge having a port in fluid communication with theflow channel for intake and expulsion of a biological fluid sample,wherein the flow channel comprises a sample stabilizer disposed within aportion of the flow channel.
 14. The biological fluid collection deviceof claim 13, wherein the cartridge is adapted to receive amulti-component blood sample having a cellular portion and a plasmaportion via the port.
 15. The biological fluid collection device ofclaim 14, further comprising an actuation member in fluid transfercommunication with the flow channel, the actuation member transitionablebetween an initial position in which the multi-component blood sample isstored within the cartridge and an activated position in which at leasta portion of the multi-component blood sample is expelled from the port.16. The biological fluid collection device of claim 15, wherein theactuation member is transitioned to the activated position only after aportion of the multi-component blood sample has mixed with the samplestabilizer.
 17. The biological fluid collection device of claim 13,wherein the puncturing element is part of a contact activated lancetdevice.
 18. The biological fluid collection device of claim 14, furthercomprising a separation member disposed at least partially within aportion of the flow channel, the separation member adapted to restrainthe cellular portion and allow the plasma portion to pass therethrough.19. The biological fluid collection device of claim 14, wherein with thecartridge disconnected from the housing, the port is adapted forconnection to a point-of-care testing device for closed transfer of atleast a portion of the multi-component blood sample from the cartridgeto the point-of-care testing device.
 20. The biological fluid collectiondevice of claim 14, wherein the cartridge flow channel comprises a ventto atmosphere and wherein the vent includes a porous membrane adapted toallow air to pass therethrough and retain the multi-component bloodsample therein.